Refractory or relapsed follicular lymphoma

Active Ingredient: Zanubrutinib

Indication for Zanubrutinib

Population group: only adults (18 years old or older)
Therapeutic intent: Adjunct intent

Zanubrutinib in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

For this indication, competent medicine agencies globally authorize below treatments:

320 mg once daily or 160 mg twice daily

For:

Dosage regimens

Regimen A: Oral, 320 milligrams zanubrutinib, once daily.

Regimen B: Oral, 160 milligrams zanubrutinib, 2 times daily.

Detailed description

The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily or divided into two doses of 160 mg twice daily. Treatment with zanubrutinib should be continued until disease progression or unacceptable toxicity.

Zanubrutinib in combination with obinutuzumab

Zanubrutinib must be administered orally before obinutuzumab infusion. The recommended dose is obinutuzumab 1,000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of every 28-day cycle from Cycles 2 to 6. At the discretion of the physician, obinutuzumab may be administered 100 mg on Day 1 and 900 mg on Day 2 of Cycle 1 instead of 1,000 mg on Day 1 of Cycle 1. Obinutuzumab maintenance (one infusion every two months for up to two years) may be prescribed. Refer to the obinutuzumab SmPC for additional dosing information, including premedication before each infusion.

Dose modifications for adverse reactions

Recommended dose modifications of zanubrutinib for Grade 3 or greater adverse reactions are provided in the following table.

Recommended dose modifications for adverse reactions:

Adverse reaction Adverse
reaction
occurrence
Dose modification
(starting dose: 320 mg once daily or
160 mg twice daily)
โ‰ฅGrade 3 non-haematological
toxicities

Grade 3 febrile neutropenia

Grade 3 thrombocytopenia with
significant bleeding

Grade 4 neutropenia (lasting >10
consecutive days)

Grad 4 thrombocytopenia (lasting
>10 consecutive days)
FirstInterrupt zanubrutinib
Once toxicity has resolved to โ‰คGrade 1 or
baseline: Resume at 320 mg once daily or
160 mg twice daily
Second Interrupt zanubrutinib
Once toxicity has resolved to โ‰คGrade 1 or
baseline: Resume at 160 mg once daily or
80 mg twice daily
Third Interrupt zanubrutinib
Once toxicity has resolved to โ‰คGrade 1 or
baseline: Resume at 80 mg once daily
Fourth Discontinue zanubrutinib

Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking zanubrutinib.

For dose modification of obinutuzumab for adverse reactions, refer to the SmPC of obinutuzumab.

Missed dose

A double dose should not be taken to make up for a forgotten dose. If a dose is not taken at the scheduled time, the next dose should be taken according to the normal schedule.

Dosage considerations

Zanubrutinib can be taken with or without food.

Active ingredient

Zanubrutinib

Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

Read more about Zanubrutinib

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